Appreciate the quick response!Interesting, I think there are 2...

Appreciate the quick response!

Interesting, I think there are 2 elements to this worth exploring. First the question of whether placebo effects extend to preventing cardiac damage following chemo, i.e. could the actual function of the heart be affected by placebo?

I think this is worth revisiting, perhaps Dr T should discuss this some more with Aaron Svedlov because placebo effects have been documented in heart failure studies where the actual function of the heart is measured. There is an American Heart Journal review on this published in 1990.

The second interesting thing to consider is the fact that perhaps placebo effects might be an important part of the clinical response in cardiovascular medicine, and they should be used. At the end of the day, if part of the benefit is due to placebo shouldn't we include that when weighing whether the benefit outweighs the risk of a drug? Perhaps someone on here knows more about this?

I think the most important question though is how do regulatory bodies rate evidence that is not placebo controlled? That is what Big Pharma will care about at the end of the day. I hope Dr T and the team have done their DD here. The line of DD to follow here is around the shift of increasing recognition being give to real world evidence by the FDA and also TGA. The shift in thinking here is rather than "good evidence" , regulatory bodies want "appropriate evidence."

I hope this type of study design fits into that "appropriate evidence" catagorey, because it's hard to get passed the fact that we just will not know how much of the effect is due to the actual drug vs due to placebo with this study design. But if the FDA and TGA don't care about that then it's all good!